QA Method

4 maanden geleden

Geleen, Nederland Lonza Voltijd

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

QA Specialist Process, Method & Shipping Validation reviews and approves documentation and oversees qualification / validation/verification of QC analytical methods, validation of manufacturing, cleaning, disinfection and shipping processes.

He/she reviews and approves the validation documents required to ensure the compliant analytical, manufacturing and shipping process and provides validation knowledge support to the project when required.

He/she assures the deviations and changes are well documented and applicable corrective actions and systemic solutions are applied.

Key Responsibilities:

Overseeing Method and Process verification / qualification / validation deliverables

Review and approve process FMEA for the assessment of process parameters

Ensure the correct application of the validation requirements

Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice

Contributes to long-term strategic development of validation program and related plans and projects related to method, process, cleaning and disinfection and shipping validation.

Own QA related quality system deliverables (CAPA, Change Control) and use project management skills to coordinate the related activities, drive timely results for successful milestone completion and limit compliance risks.

Key Requirements:

Education: B.Sc / M.Sc. in Biology / Biomedical science, Life Science, or other job related discipline

Dutch working permit

English language skills, fluent

GMP experience

Relevant experience, at least 3 years in Quality control / Validation/ Manufacturing Science and Technology

Dutch working permit

Flexibility in getting the job done with appropriate quality level

Problem solving ability with holistic approach 

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfactionthatcomeswithmaking a meaningfuldifference. 

Reference: R61317

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